MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 11/13 S-ROM 40MM M SPEC-3; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Catalog Number	136541500
Medical Device Problem Codes	Material Disintegration (1177); Metal Shedding Debris (1804); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Tissue Damage (2104); Distress (2329); Discomfort (2330); Injury (2348); Not Applicable (3189); No Code Available (3191)
Date of Event	01/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient was revised to address groin pain.Doi: (b)(6) 2010.Dor: (b)(6) 2018.Left hip.
Event or Problem Description
Pinnacle litigation received.In addition to what were previously alleged, litigation alleges that friction and wear from the pinnacle metal on metal device released toxic metal debris into the patient¿s body causing elevated metal ion levels in the body, inflammation, soreness, tissue and bone loss, permanent injuries, discomfort, emotional distress, suffering and other related diseases, thereby, impairing the patient¿s activities of daily living.Added new associated contact.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Ppf alleges loosening of cup and metal wear.

• Brand Name: 11/13 S-ROM 40MM M SPEC-3
• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7224504
• Report Number: 1818910-2018-52268
• Device Sequence Number: 19086745
• Product Code: JDI
• UDI-Device Identifier: 10603295033738
• UDI-Public: 10603295033738
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K060031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2012
• Device Catalogue Number: 136541500
• Device Lot Number: 2460354
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 03/27/2018; 08/06/2018; 12/19/2018
• Initial Report FDA Received Date: 01/29/2018
• Supplement Report FDA Received Date: 04/02/2018; 08/30/2018; 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR